COMPuter-assisted Self-training to Improve EXecutive Function

Bispebjerg Hospital307 enrolled

Overview

This project explores the effects of specialized computer-based cognitive rehabilitation (CBCR) targeting executive functions in three groups of patients: Stroke, Cardiac Arrest and Parkinson's Disease. The effect of specialized CBCR is compared to completing generally cognitively stimulating activities on a computer. A total of 307 patients is expected to be enrolled. All patients will complete a neuropsychological test battery assessing executive functions at inclusion, directly after the eight-week training period and at follow-up three months after the end of the intervention period. Furthermore, all patients will answer questionnaires concerning quality of life and ADL-measures at baseline, after the intervention and at follow-up. All patients will train for a period of 8 weeks, 5 times a week for 60 minutes regardless of their group allocation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

307

Conditions

Parkinson Disease Stroke Cardiac Arrest Cognitive Dysfunction Executive Dysfunction

Interventions

Computer-based cognitive rehabilitation (CBCR)BEHAVIORAL

CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions.

General computer-based cognitive stimulationBEHAVIORAL

For this trial we have developed a webpage for general cognitive stimulation, which is designed to provide general computer-based cognitive stimulation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A diagnose of stroke, cardiac arrest or Parkinson's disease. * Aged 18 years or older. * Impaired working memory measured with CABPad working memory test, cut off for inclusion: 5 symbols or less backwards * Computer and internet access at home. * Providing informed consent. Inclusion criteria specific for stroke * Inclusion within 6 months post-stroke * Stroke confirmed by clinical findings and imaging, both AIS and ICH is allowed. * Initial stroke severity \>/= NIHSS 3. Inclusion criteria specific for cardiac arrest • Inclusion within 6 months post ictus. Inclusion criteria specific for Parkinson's disease * Clinical diagnosis of PD. * Anti-parkinsonian medical treatment (dopaminergic or other). Exclusion Criteria: * Informed consent not provided * Other neurological or psychiatric disease which is expected to influence the patient's ability to participate in the trial according to the investigator * Not able to participate according to investigator Exclusion criteria specific for stroke * Patients with massive anosognosia for executive dysfunction or patients with no subjective feeling of executive dysfunction (Patient sustains total denial of executive symptoms over time) * Patients with severe aphasia, in which it is unclear whether the patient's performance on a neuropsychological test-battery is due to aphasia and not executive dysfunction. Exclusion criteria specific for cardiac arrest • None Exclusion criteria specific for PD • Diagnosis of PD Dementia according to the MDS PD Dementia criteria

Locations (2)

Bispebjerg Hospital

Copenhagen, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Outcomes

Primary Outcomes

CABPad Working Memory Test

Test of working memory. The higher score the better (theoretically infinite score)

Time frame: After the end of the intervention (8 weeks after baseline)

Secondary Outcomes

CABPad Working Memory Test - 3 months follow-up

Test of working memory. The higher score the better (theoretically infinite score)

Time frame: At follow-up visit 3 months after end of intervention

Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)

Questionnaire concerning activities of daily living. 0-3 points on an 8-item scale, the fewer points the better.

Time frame: At follow-up visit 3 months after the end of the intervention

Trail Making A

Test of processing speed and visual attention. The lower score the better (theoretically infinite score)

Time frame: Directly after the intervention, eight weeks after inclusion

Trail Making A

Test of processing speed and visual attention. The lower score the better (theoretically infinite score)

Time frame: At follow-up visit 3 months after the end of the intervention

Trail Making B

Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score)

Time frame: Directly after the intervention, eight weeks after inclusion

Trail Making B

Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score)

Central Contacts

Hanne Christensen, Professor

CONTACT

+45 38 63 50 70 hanne.krarup.christensen@regionh.dk

Katrine Sværke, M.Sc. Psych.

CONTACT

004521251087 katrine.svaerke.schioeler@regionh.dk

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: At follow-up visit 3 months after the end of the intervention

SDMT

Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score)

Time frame: Directly after the intervention, eight weeks after inclusion

SDMT

Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score)

Time frame: At follow-up visit 3 months after the end of the intervention

Phonological verbal fluency test

Test of verbal phonological fluency. The higher score the better (theoretically infinite score)

Time frame: Directly after the intervention, eight weeks after inclusion

Phonological verbal fluency test

Test of verbal phonological fluency. The higher score the better (theoretically infinite score)

Time frame: At follow-up visit 3 months after the end of the intervention

Categorical verbal fluency test

Test of verbal categorical fluency. The higher score the better (theoretically infinite score)

Time frame: Directly after the intervention, eight weeks after inclusion

Categorical verbal fluency test

Test of verbal categorical fluency. The higher score the better (theoretically infinite score)

Time frame: At follow-up visit 3 months after the end of the intervention

Fear questionnaire

Questionnaire with 24 items concerning fear on a scale from 0 to 8 where 8 indicates a higher degree of avoidance due to fear

Time frame: Directly after the intervention, eight weeks after inclusion

Fear questionnaire

Questionnaire with 24 items concerning fear on a scale from 0 to 8 where 8 indicates a higher degree of avoidance due to fear

Time frame: At follow-up visit 3 months after the end of the intervention

mrs: Modified Rankin Scale

Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead): Higher score indicates more severe disability.

Time frame: Directly after the intervention, eight weeks after inclusion

mrs: Modified Rankin Scale

Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead). Higher score indicates more severe disability.

Time frame: At follow-up visit 3 months after the end of the intervention

IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)

Cognitive decline in the elderly, reported by partner. A scale of 16 items from 1 (much better) to 5 (much worse). Higher score indicates more severe disability.

Time frame: Directly after the intervention, eight weeks after inclusion

IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)

Cognitive decline in the elderly, reported by partner. A scale of 16 items from 1 (much better) to 5 (much worse). Higher score indicates more severe disability.

Time frame: At follow-up visit 3 months after the end of the intervention

EuroQol-5 domain (EQ-5D-5L)

Quality of life scale with 5 domains, each rated from 1-5 indicating slight to severe disability . Higher score indicates more severe disability. Completed by patient and partner

Time frame: Directly after the intervention, eight weeks after inclusion

EuroQol-5 domain (EQ-5D-5L)

Quality of life scale with 5 domains, each rated from 1-5 indicating slight to severe disability. Higher score indicates more severe disability. Completed by patient and partner

Time frame: At follow-up visit 3 months after the end of the intervention

PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinson Disease)

Quality of Life questionnaire in patients with Parkinson's Disease. A scale with 39 items rated from 1 (never) to 5 (all the time / Can not do at all). Higher score indicates more severe disability.

Time frame: Directly after the intervention, eight weeks after inclusion

PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinsons Disease)

Quality of Life questionnaire in patients with Parkinson's Disease. A scale with 39 items rated from 1 (never) to 5 (all the time / Can not do at all). Higher score indicates more severe disability.

Time frame: At follow-up visit 3 months after the end of the intervention

Compliance

Monitoring of total time spent training in minutes

Time frame: Directly after the intervention, eight weeks after inclusion

PHQ-9 (Patient health questionnaire 9)

Questionnaire about health of patient with 9 items rated on a 4 point scale from 0 (not at all) to 3 (almost every day). Higher score indicates more severe disability.

Time frame: Directly after the intervention, eight weeks after inclusion

PHQ-9 (Patient health questionnaire 9)

Questionnaire about health of patient with 9 items rated on a 4 point scale from 0 (not at all) to 3 (almost every day). Higher score indicates more severe disability.

Time frame: At follow-up visit 3 months after the end of the intervention

2) visual analogue scale (1-10)

After last session: how much they liked doing the training and if they would recommend the intervention to somebody else in their situation. Higher score indicates they liked the training more.

Time frame: Directly after the intervention, eight weeks after inclusion

Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)

Questionnaire concerning activities of daily living. 0-3 points on an 8-item scale, the fewer points the better.

Time frame: Directly after the intervention, eight weeks after inclusion